Book:The Comprehensive Guide to Physician Office Laboratory Setup and Operation/The clinical environment/Regulatory compliance: CLIA

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1.5 Regulatory compliance: CLIA

In 1988, CLIA was passed as an amendment to the original 1967 legislature.[1] CLIA attempts to ensure the accuracy, reliability, and timeliness of test results regardless of where the test was performed. As part of this process, seven different criteria are used to gauge and assign one of three complexity levels to laboratory devices, assays, and examinations: high, moderate, and waived.[2][3] Clinical laboratories handling specimens originating from the U.S. and its territories must apply for a CLIA certificate that is appropriate for the type of testing it performs.

The POL largely conducts CLIA-waived tests, with 70.6 percent of all non-exempt POLs in the U.S. running on a CLIA certificate of waiver as of May 2022.[4] These tests are recognized as simple to perform with a low risk of erroneous results and include among others urinalysis for pregnancy and drugs of abuse, blood glucose and cholesterol tests, and fertility analysis. Despite the simplicity of a waived test, it "needs to be performed correctly, by trained personnel and in an environment where good laboratory practices are followed."[5] As such, CMS provided additional enforcement of labs with CLIA certificates of waiver in the 2010s, conducting on-site visits to approximately two percent of such labs to verify quality testing, regulatory compliance, and test appropriateness.[6]

CLIA-waived testing is not the only testing that goes on at a POL. In some cases, a POL may also offer moderate-level provider performed microscopy (PPM) testing (17.5 percent of all POLs as of May 2022[4]), depending on the office specialty.[7] To perform this type of testing in addition to waived testing, a PPM certificate is required.

For POLs exclusively conducting waived testing, anyone can be the laboratory director; however, some states have different requirements, so it is important the POL checks with their local regulatory body when hiring staff for the laboratory. POLs that also incorporate PPM testing have different requirements for directors, who "must meet specific education, training and experience under subpart M of the CLIA requirements."[8]

References

  1. "Public Law 100-578" (PDF). United States Statutes at Large, Volume 102. 31 October 1988. https://www.govinfo.gov/content/pkg/STATUTE-102/pdf/STATUTE-102-Pg2903.pdf. Retrieved 18 April 2022. 
  2. Centers for Disease Control and Prevention (6 August 2018). "Clinical Laboratory Improvement Amendments (CLIA): Test complexities". https://www.cdc.gov/clia/test-complexities.html. Retrieved 18 April 2022. 
  3. "CLIA Categorizations". U.S. Food and Drug Administration. 25 February 2020. https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-categorizations. Retrieved 18 April 2022. 
  4. 4.0 4.1 Centers for Medicare and Medicaid Services, Division of Laboratory Services (May 2022). "Enrollment, CLIA exempt states, and certification of accreditation by organization" (PDF). http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf. Retrieved 17 May 2022. 
  5. "Waived Tests". Centers for Disease Control and Prevention. 3 September 2021. https://www.cdc.gov/labquality/waived-tests.html. Retrieved April 18, 2022. 
  6. "Certificate of Waiver Laboratory Project". Centers for Medicare and Medicaid Services. 27 February 2014. Archived from the original on 02 January 2019. https://web.archive.org/web/20190102181225/https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Certificate_of_-Waiver_Laboratory_Project.html. Retrieved 18 April 2022. 
  7. Garrels, Marti; Oatis, Carol S. (2014). Laboratory and Diagnostic Testing in Ambulatory Care: A Guide for Healthcare Professionals (3rd ed.). Elsevier Health Sciences. pp. 368. ISBN 9780323292368. https://books.google.com/books?id=LM9sBQAAQBAJ. Retrieved 18 April 2022. 
  8. "How to Apply for a CLIA Certificate, Including International Laboratories". Centers for Medicare and Medicaid Services. 1 December 2021. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/How_to_Apply_for_a_CLIA_Certificate_International_Laboratories. Retrieved 18 April 2022.